NAGLREITER™ is the only Medical Device Development Organization (MDDO) that has the passionate expertise, professional experience, and proven process to deliver unsurpassed medical device product development services – from concept to commercialization, or any required stage in between – that minimizes risk and optimizes the opportunity for financial return.

We do this by engaging our device industry experts, who are driven by an entrepreneurial spirit, who maintain specific product category expertise, who stay ahead of ever-evolving clinical practices, and follow proven quality systems, to ensure device development success.

client-chart

Dedicated Client Liaison

Single point of contact with deep sense of ownership and accountability

  • Streamlines client communication
  • Extensive experience across numerous medical specialities

 

Broad and Controlled

Both Quality and Business procedures

  • Covers the complete New Product Development lifecycle

 

Flexible and Simple

Our role with insourcing is whatever the client wants it to be

  • The client may assume complete control of the process, or not

 

Procure and Prepare

We purchase what a project requires

  • Insourcing activities include calibration, preventative maintenance and licensing fees

 

Unique Client Benefits

The ELEVATOR™ Approach provides an array of unique benefits to your business incubation including:

  • NO LEARNING CURVE – NAGLREITER™ is an expert in the Medical Device field and latest regulatory requirements with a proven track record
  • NO MISSING DESIGN HISTORY FILE – NAGLREITER™ provides a proven, ISO-certified QMS that ensures appropriate documentation for regulatory submissions
  • NO MISALIGNED ACTIVITIES – NAGLREITER™ provides a single point-of-contact who managers and addresses all project needs, and has expertise within the required medical specialty
  • NO FRAGMENTED CONTRACTS – NAGLREITER™ provides a complete service agreement that covers the life of your program, and allows desired flexibility throughout its term
  • NO CONFUSING REGULATORY OWNERSHIP – NAGLREITER™ allows the client to be the ‘spec developer’ and ‘manufacturer’ throughout the entire development process
  • NO HIDDEN IP COST – NAGLREITER™ makes available ownership of the newly created IP to the client as part of the service fee
  • NO TRANSFER COST – NAGLREITER™ allows the product to be fully developed within the company’s own quality system, eliminating the need for future transfer and facilitating scale-up at new manufacturing location

 

Service Agreement Advantage

  • Minimizes Capital Investment Costs
  • Minimizes Quality System Investment Costs
  • Minimizes Human Resource Investment Costs

 


 
 NAGLREITER™ vs Contract Manufacturers

Client Options NMDDO Contract MFG
• Utilize Equipment only Yes No
• Utilize Quality System only Yes No
• Utilize Workforce only Yes No
• Client utilizes manufacturing services without a need for a supply agreement Yes No